# FDA 483 - Nishizawa Electric Meters Manufacturing Co Ltd - May 19, 2023

Source: https://www.keypedia.com/records/483/nishizawa-electric-meters-manufacturing-co-ltd/71d7a0c8-d8ed-495e-90fe-4d02b7ba68f0

> FDA 483 for Nishizawa Electric Meters Manufacturing Co Ltd on May 19, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Nishizawa Electric Meters Manufacturing Co Ltd
- Inspection Date: 2023-05-19
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Nishizawa Electric Meters Manufacturing Co. Ltd in Sakaki-Machi, Japan, revealed a significant issue with the firm's document control procedures. The company failed to adequately establish and maintain these procedures, specifically by not keeping document change records for several revisions. This indicates a lapse in the firm's quality system compliance.

## Related Officers

- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.keypedia.com/companies/nishizawa-electric-meters-manufacturing-co-ltd/80a08604-e260-4d9e-90bb-2188cd948054

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd